News

Azopharma Integrates Units, Expands Services

Azopharma Product Development Group (Booth 1801) has integrated its eight service divisions as part of an effort to streamline its approach to product development for small biotechs and large pharma alike, supporting both full development and specialty stand-alone projects.

The Azophrma Product Development Group — previously made up of Azopharma, APIcross, IQsynthesis, AniClin, Cyanta, ADMEQuant, AvivoClin, and Acromon — has been consolidated into three divisions: Azopharma Contract Pharmaceutical Services, AniClin Preclinical Services, and AvioClin Clinical Services.

At a press event during AAPS, a spokesman for the company said that Azopharma is focusing on its core services and has no acquisition plans for the near future. In the past year, Azopharma expanded despite the down economy, adding to its analytical services in Welwyn Garden City, UK and in Maryland Heights, MO, microdosing and central lab services to its pharmacology research facility in Daytona Beach FL, and more recently, new cytotoxic manufacturing suites for clinical trial materials at its (south Florida) Hollywood location.

Microdosing, a trend among pharmaceutical and regulatory agencies, allows companies to make “kill or carry” decisions with earlier pharmacokinetic and pharmacodynamic data in humans. In microdosing studies, drug substance is dosed sufficiently low not to have observable pharmacological activity, but to screen the ADME properties of several drug candidates. These studies have seen a big push from the FDA through its Critical Path initiative.

Cytotoxic compounds are becoming more prominent in the oncology drug realm. These compounds are difficult and dangerous to work with. With its three new manufacturing suites, equipment, and analytical instrumentation, the company is better positioned to support cytotoxic and highly potent compounds for development. Currently Azopharma is manufacturing two niche commercial products for clients: a cytotoxic product and a highly potent compound. With use of cytotoxics predicted to grow, the spokesman contended that the company is very interested in this smaller volume market.

Azopharma is also tapping into strategic partnerships. The group recently entered ones with Pharmanet to leverage complementary services through business development and co-promotion, and Immunregen, under which Azopharma provides development services in exchange for taking equity in the company.

Metrics Study Examines Value of Active-Only Powder-In-Capsule Dosing

Although active-only powder in capsule approaches are increasingly popular for Phase I trials, they may result in significantly slower, more erratic and less complete in vitro dissolution for some poorly soluble compounds – with the potential to skew in vivo results and delay or abandon work into promising new drugs. So says Dr. Michael Ruff, CPIP, vice president of pharmaceutical development at Metrics Inc. (Booth 2133). Dr. Ruff presented his research findings during a poster session on Nov. 9 at AAPS.

In a recent study, Dr. Ruff compared the in vitro dissolution of a non-formulated, active-only powder in capsule to that of a formulated capsule in the case of a poorly soluble drug intended for Phase I trials. He reported that his findings represent a cautionary tale for the pharmaceutical industry, which has increasingly taken an active-only, powder-in-capsule approach towards conducting Phase I first-time-in-man trials. This approach enables companies to skip significant formulation and analytical development activities and put prospective new compounds into patients more quickly.

“Going with a drug-only-in-capsule approach can move up first-time-in-man clinical dosing by two to four months, depending on the complexity of the intended dosage form,” Dr. Ruff said. But in his study examining a typically poorly soluble compound, he found that the powder-in-capsule approach resulted in significantly slower, more erratic and less complete in-vitro dissolution. This situation could potentially yield false negative in vivo results, delaying future trials or causing researchers to abandon studies of potentially beneficial new drugs, he warned.

“I recognize that there’s tremendous pressure to reach that first-in-man milestone – it’s what the industry and shareholders expect,” Dr. Ruff said. “So I’m not suggesting that researchers never do active-only powder in capsule. But this limited data supports the theory that agglomeration of micronized, poorly soluble active ingredients can pose a problem for this approach.”

Headquartered in Greenville, NC, Metrics provides pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.

Executive Moves: Almac Sciences

Almac Sciences, part of Almac Group (Booth 2600), has made several appointments.

Denis Geffroy has been named vice president Business Development, with global responsibility. Mr. Geffroy was most recently senior business manager Europe and had been leading Almac Sciences’ rapidd™ early stage development offering.

He joined Almac Sciences in 2004 and has notably developed the European business by adding numerous major pharmaceutical clients to the Almac Sciences portfolio. His new remit includes lab synthesis, PRD chemistry, GMP manufacturing, analytical services, peptide synthesis, radio-labelling, solid state chemistry and biocatalysis. He previously held technology and commercial roles with Chiroscience/ChiroTech and ICI/Synetix Chiral Technologies.

Dr. Charles Shields is joining Almac Sciences as vice president Peptides Operations. Dr. Shields was formerly U.S.-based vice president Global Business Development for Avecia’s oligonucleotides (DNA medicines) business. Prior to 2003 he held a series of senior positions with Avecia, including New Products Development Manager with its Ink Jet Printing Materials business.

Helen McKeever has been named as preclinical program manager, responsible for implementation of rappid™ early stage development programmes. A biochemist with more than 20 years’ CRO experience, Ms. McKeever was most recently senior project manager with Covance.

Almac Sciences president and managing director Stephen Barr remarked, “These appointments bring high levels of proven customer service leadership and delivery in key areas of Sciences’ business, and further increase our emphasis on added value services.”

Quay Pharma To Expand in 2010

Quay Pharma (Booth 2412) is investing nearly $4 million to move to a new purpose-designed factory and headquarters, allowing the company to greatly increase its development and clinical trial manufacturing capacities. The move is expected to create around 52 jobs in the next three years.

The new facility in North Wales, UK, is close to Quay Pharma’s existing premises in the Wirral, and brings together the company’s entire range of services — currently housed in two separate facilities — under one roof.The 40,400-sq.-ft. building, which is four times the size of its existing premises, will feature a variety of state-of-the-art equipment that will enable the company to meet increasing demand for its specialist capabilities, including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging.

In particular, the expanded operation will provide the opportunity for the further development of Quay Pharma’s expertise in oral dosage form design and development, especially for new chemical entities that exhibit poor solubility and bio-availability, according to the company.

“Our extensive knowledge and experience can play a crucial role in the critical early stages of drug development and in recent years we have seen increasing demand for our services,” said Quay Pharma’s chief executive, Mike Rubinstein. “By creating this new advanced facility to our specific requirements, we will be able to offer an enhanced level of support to our clients.”

The move is planned for January 2010, and will be phased to ensure work on existing client projects is maintained throughout. The new facility is being part funded by a grant from the Welsh Authority Government.

Avantium, AMS Enter CSP Pact

Avantium (Booth 2061) and Avant-garde Materials Simulations (AMS) have entered into a collaboration for the further development and commercialization of Crystal Structure Prediction (CSP) with AMS’ GRACE software. Pharmaceutical companies can use CSP to predict the crystal structures of their drug compounds. CSP provides an essential approach to significantly reduce the risk of missing a more stable crystal form.

AMS will further develop the software to accelerate the calculations and broaden the range of compounds for which it can be used. AMS will also perform the predictions for third parties. Avantium will develop efficient experimental strategies to physically generate the predicted crystal forms and commercialize Crystal Structure Prediction as a stand-alone service or in combination with experimental programs.

CSP, as developed by AMS, is a breakthrough approach, showing for the first time that the reliable prediction of crystal forms is feasible. AMS in collaboration with the Institute of Pharmaceutical Innovation at the University of Bradford were the first participants ever to score a 4 out of 4 success rate at the 2007 CSP Blind Test.

“The scope of applicability and the accuracy of CSP will continue to improve rapidly,” said Marcus Neumann, managing director of AMS. “The next key challenge is to actually produce predicted but not yet observed forms by rational experiment design. With Avantium Pharma we have found the ideal partner to write the next chapter of the story.”

“The CSP technology is a great extension of our service portfolio,” remarked Guus Scheefhals, chief operating officer of Avantium Pharma. “The predictions will prevent overlooking the most stable crystal form, which will strengthen the IP position of our clients and will help to reduce the risk of crystal form inter-conversions in drug development.”

SMI Invests $10 Million in HealthSport

SMI Manufacturing (Booth 1709) has agreed to invest $10 million into HealthSport, Inc., a formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion. The investment is expected to accelerate HealthSport's growth and strengthen its alliances with large pharmaceutical companies.

"The first phase of our relationship with HealthSport was accomplished in July of this year with the signing of the manufacturing agreement between the two companies. This investment represents the next step in that relationship, which is to begin the process of making this breakthrough technology available to the pharmaceutical industry on a worldwide basis," stated Kevin Taheri, SMI's chief executive officer.

"It has been apparent for some time that there is a very strong synergistic relationship between SMI and HealthSport. We are looking to take advantage of that relationship to not only produce dietary supplement and OTC film strip products, but also to begin working with pharmaceutical companies to enter the highly profitable prescription pharmaceutical market," stated Hank Durschlag, chief executive officer of HealthSport. "Our drug delivery platform is ideal for many drugs already used everyday."

SMI and HealthSport signed a stock purchase agreement pursuant to which SMI will invest the $10 million into HealthSport in exchange for a 55% percent stake in HealthSport. Closing of the transaction is anticipated to occur in the next 15 to 20 days. At the time of the closing, SMI will deliver to HealthSport $2 million and a promissory note for $8 million that SMI will pay in five installments through the final scheduled payment on June 30, 2010. Funds from the investment will be used to strengthen HealthSport's working capital position, provide funds for R&D and enhance HealthSport's current manufacturing plant, creating a state-of-the-art, GMP compliant R&D and production facility.

Executive Appointments at Patheon

Patheon (Booth 1232) has named William E. Weiser, Ph.D. to the role of group director, Pharmaceutical Development Services (PDS), Analytical Development at the company's Kit Creek laboratory in Research Triangle Park, NC. Also, Anthony Qu, Ph.D. has been named group director of the PDS operation in Cincinnati, OH.

"We are so pleased that we have been able to add these two individuals to our organization," said Dr. Colin Minchom, Patheon's vice president PDS North America. "I am confident that our customers and employees will benefit from their broad expertise as leaders and as scientists in research and development."

Dr. Weiser has over 20 years experience in the pharmaceutical industry. Most recently he served as general manager for Liquidia Pharmaceuticals with responsibility for establishing pharmaceutical development operations for nanoparticle therapeutics as well as formulation and analytical development capabilities. He was vice president of analytical chemistry at Cardinal Health/Magellan Laboratories, where he contributed to the growth of their contract pharmaceutical analytical services business. Dr. Weiser also held positions of increasing leadership in Pharmaceutical Development at Burroughs Wellcome Co.

Dr. Qu, with almost 20 years experience in the pharmaceutical industry, is returning to Patheon from his most recent position as vice president of product development at Apotex. His previous Patheon experience included responsibilities as senior director of PDS Global Analytical Operations and director/manager, PDS Analytical Development in Mississauga, ONT, Canada. He has also held positions in R&D and regulatory affairs at Biovail and Taro Pharmaceuticals.

Visit Patheon at Booth 1232!

sigma-tau Group Acquires Enzon Specialty Pharma

Enzon Pharmaceuticals (Booth 611) will sell its specialty pharmaceutical business, including its CMO operations, to the sigma-tau Group for $300 million plus an additional amount of up to $27 million based on success milestones. Enzon will also receive royalties of 5 to 10% on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014.

Enzon’s specialty pharmaceutical business includes four marketed products: Oncaspar, Adagen, DepoCyt, and Abelcet, as well as the manufacturing facility in Indianapolis, IN which will be purchased by a U.S. subsidiary of Sigma-Tau Pharmaceuticals, Inc., based in MD. Sigma-Tau Pharmaceuticals will distribute the products in the U.S. market.

After the sale of these assets, Enzon’s businesses will consist of its royalties, Peg SN38 and our LNA and PEG technology platforms. “Enzon’s board is evaluating options to return most of the value of this sale to shareholders,” stated Alex Denner, chairman.

“sigma-tau is a great strategic fit for this business, as they have the presence and expertise to effectively market these products in all geographic areas,” said Jeffrey H. Buchalter, Enzon’s president and chief executive officer.

sigma-tau is a global R&D driven, Italian-owned pharmaceutical company dedicated, among other areas, to developing and commercializing medicines for rare diseases. This acquisition will expand sigma-tau’s current presence in the U.S. and in new therapeutic areas.

Marc Tewey, vice president, commercial operations of Sigma-Tau Pharamceuticals, confirmed that the company plans to continue the CMO business.

“sigma-tau is dedicated to providing novel therapeutics to patients suffering from rare diseases and other unmet medical needs,” said Claudio Cavazza, sigma-tau’s president. “Through the acquisition of Enzon’s specialty pharmaceutical business, we will increase our presence in the field of rare diseases with products of great value which are the result of an outstanding research activity. sigma-tau is determined to continue Enzon’s excellent work, especially in the field of rare diseases which is a particularly stimulating one as it aims at tackling life-threatening conditions which all too often affect the very young.”

Drop by DPT To Enter 2010 AAPS Contest!

Win free registration and hotel for 2010 AAPS, courtesy of DPT (Booth 1701)!

Register with DPT for a chance to win FREE registration and hotel stay during the 2010 AAPS Annual Meeting & Expo in New Orleans. Entry tickets are in AAPS registration bags (or you can stop by DPT's booth to pick one up).

Drop off your entry ticket at booth 1701 for your chance to win.One winner will be selected each day of the tradeshow!

(NOTE: must be a pharmaceutical, biotechnology or consumer healthcare employee to enter.)

Catalent, Endotis in Alliance

Catalent Pharma Solutions (Booth 1301) has entered into a strategic alliance with Endotis Pharma for the development of oral formulations of synthetic oligosaccharides.

Using Catalent's drug delivery technologies, the two companies will collaborate exclusively to develop certain oral formulations of small-glycol drugs. Oral formulations of synthetic oligosaccharides will allow full exploitation of the therapeutic potential of small-glycol drugs, which to date are administered only intravenously or subcutaneously.

Catalent and Endotis are initially focusing on the preclinical development of Endotis' EP37151 compound. EP37151 is a first-in-class oral synthetic oligosaccharide anticoagulant which, as an indirect factor Xa inhibitor, acts via antithrombin activation. The companies expect to initiate a Phase I clinical trial program during the second quarter of 2010, and hope to have more oral anticoagulants enter development within the next year.

"This collaboration with Endotis, based upon a unique combination of complementary expertise, has been providing exciting results, proving that the various technical hurdles associated with the oral delivery of small-glycol drugs can be overcome," said Tom Stuart, group president of Catalent's Oral Technologies segment.

Visit Catalent Pharma Solutions at Booth 1301!

DSM, Galenix in Manufacturing Pact

DSM Pharmaceutical Products (Booth 1333) has entered a manufacturing alliance with Galenix of Saint Jean D'Illac, France, in which DSM will be the preferred commercial scale manufacturing partner for Galenix commercial products on a global basis.

DSM and Galenix will collaborate on business development opportunities co-marketing Galenix drug delivery technologies, based on the strength of Galenix in drug product development and clinical services and DSM in process development, scale up and commercial scale pharmaceutical manufacturing.

Pieter de Geus, DSM Pharmaceuticals' senior vice president, R&D stated, "These innovative drug delivery technologies enhance our offering in the field of pharmaceutical development services and complement our portfolio of drug delivery technologies. The collaboration with Galenix clearly demonstrates DSM's commitment to bringing improved drug delivery to markets globally."

Hans Engels, president of DSM Pharmaceuticals, added, "The alliance brings out the best of both parties. Combining innovative formulations with flawless transition into commercial products creates an attractive value proposition for any drug company."

Jerome Besse, chief executive officer of Galenix, commented, "This is truly a win-win situation. Galenix is privileged in working with DSM to generate value for our customers. The partnership fits with our strategic intention of expanding service offerings to the North America market, and also with DSM's expansion of sales & marketing focus in Europe."

No financial terms were disclosed.

ABC Laboratories Expands Biotech Development Services

Analytical Bio-Chemistry Laboratories (ABC, Booth 1119) has expanded its offerings to include comprehensive support for large molecule development.

"This recent investment in biotech development services complements ABC's long history of ELISA, RIA and EIA experience and bioanalytical support. It also leverages ABC's extensive analytical capabilities to provide our clients with more comprehensive support for both large and small molecules," said John Bucksath, general manager and senior vice president of ABC's Pharmaceutical Services division.

To lead the development of a dedicated biotech team and laboratory, ABC recruited industry veteran, John C. Anders, Ph.D., who brings more than 24 years of experience in biopharmaceutical development from both the sponsor and CRO sides of the business. Dr. Anders has held several leadership positions building and leading advanced CGMP biotechnology analytical laboratories, and has expertise in time-tested and new technologies in protein chemistry, analytical methods and analysis of macromolecules by various methods. He played a major role in developing a pipeline of seven genomic expression tests for diagnosis and risk assessment of various types of cancer, including the successful completion of a pre-IND application to the FDA and development of a clinical protocol slated to begin soon.

Dr. Anders has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography. To ensure the team is well equipped to meet client demand, ABC has invested in a leading-edge biotech lab housed in ABC’s new, 90,000-sq.-ft. pharmaceutical development facility in Columbia, MO.

“Despite a challenging economic environment, 2009 was a positive year for ABC Laboratories,” said Mr. Bucksath. "Recent investments in people, processes and systems have resulted in 13% growth over 2008 and positioned us well to deliver on our customer’s needs in the years to come.”

Lonza in Manufacturing Pact with ProChon Biotech

ProChon Biotech, Ltd. has selected Lonza (Booth 2800) to manufacture its fibroblast growth factor (FGF2v) variant at its Hopkinton, MA facility. FGF2v is a key regulator of cellular processes involved in blood vessel formation, wound healing and the remodeling of bone and cartilage and is a component of ProChon's BioCart Cartilage Regeneration System.

"With an unparalleled track record in contract manufacturing, Lonza is the ideal partner to manufacture our fibroblast growth factor system," said Patrick O'Donnell, chief executive officer of ProChon. "As we accelerate the BioCart clinical program at medical centers across the country, it is vitally important to have immediate access to our core technology and working with Lonza will make this a reality. We look forward to working with Lonza to develop FGF2v as we move toward our goal of bringing mobility to millions of people who suffer from cartilage injuries."

"We are very pleased to enter this collaboration with ProChon to advance a critical new biotherapy for cartilage regeneration," said Dr. Stephan Kutzer, head of Lonza Custom Manufacturing. "We look forward to supporting ProChon with innovative development services and the latest in biopharmaceutical manufacturing technologies and expect this to be the basis for a successful, long-term relationship."

See Lonza at Booth 2800!

Althea Adds Formulation Development to Contract Services Slate

Althea Technologies (Booth 819) has added customized formulation development services to its portfolio. The services will be overseen by newly appointed Dr. James Matsuura, who takes the title director of Formulation Development.

According to a company statement, "This investment in an experienced team of formulation and analytical scientists, along with new laboratory facilities and state-of-the-art equipment, enhances and complements Althea's existing expertise and capabilities in cGMP biologics manufacturing and aseptic filling of injectable products, and completes the full integration of development and manufacturing services available for clients from early-stage development through commercial supply."

The new formulation laboratories are an expansion to the clinical manufacturing facility located on the San Diego campus and are further supported by the analytical expertise of Windrose Analytica, which Althea acquired earlier this year. "The addition of our new formulation development laboratories is the perfect complement to our advanced protein and peptide analytical capabilities, and will allow us to bring our clients' products into the clinic with unmatched speed, efficiency and effectiveness," noted Dr. Alan Herman, vice president of Product Development & chief scientific officer.

"We are delighted to have Dr. James Matsuura join Althea. His many years of experience bring added value to clients in helping them with the complexities of developing protein formulations for both clinical trials and product launch in our new commercial manufacturing facility," commented Dr. Shabbir Anik, Althea's president and chief executive officer.

The expanded facilities include a new development lyophilizer, which allows the group to optimize lyophilization cycles for products requiring enhanced stability. The new formulation laboratory and staff, operating closely with the analytical development group, complete Althea's product development group and enable Althea to support clients with critical development steps, as well as the manufacture of API and finished product.

Micromeritics and Surface Measurement Systems Announce Global Strategic Collaboration

Surface Measurement Systems Ltd. (Booth 2147) and Particulate Systems, a brand of Micromeritics Instrument Corp. (Booth 2251), have signed a global strategic collaboration. The collaboration will draw on the combined knowledge and experience of both companies in the design and development of advanced analytical equipment for the characterization of particulate, porous, and complex materials. Working together, both companies will strengthen their ability to deliver customer-focused instrumentation solutions globally, according to a joint statement.

In the initial phase of this collaboration, Particulate Systems will have the exclusive distribution rights for key SMS products in selected regions of the U.S. as well as in South America, Central America, and the Middle East. These products include the DVS Dynamic Vapor Sorption systems that utilize dynamic gas flow and the gravimetric technique to produce high-resolution adsorption and desorption isotherms of water and organic vapors on essentially any solid material. In addition, SMS will extend its service and support for customers in the U.S. via the Particulate Systems’ extensive aftercare network. Particulate Systems will also have co-distribution rights to sell Surface Measurement Systems products in China.

Particulate Systems and SMS will begin organizing joint academic meetings, symposia, and other academic training programs to advance the development of particle and sorption technology starting in October 2009.

Preston Hendrix, president of Micromeritics, stated, “Collaboration between the two organizations enhances our ability to offer advanced analytical tools to guide research, resolve problems in production and QC, and to expand the understanding of material structure in general. Joining forces with SMS provides the customers of both companies additional options for solving their analytical needs.”

Dr. Daryl Williams, managing director and founder of SMS, added, “This new relationship builds on both a business and product synergy between our two companies which will allow us to provide total instrumentation solutions for many new research and development sectors.”

Stelmi To Host Microbiology Seminar

Stelmi (Booth 1000) will host a seminar at 9:30 a.m. on Tuesday, Nov. 10, covering the mastery of microbiological and particulate cleanliness in the production RTS and RTU elastomeric closures for pre-filled syringes and vials.

Drawing on Stelmi's experience as a specialist in rubber components for pharmaceutical primary packaging, the seminar will feature targeted presentations on the reduction of microbiological and particulate contamination in the production of rubber closures, with special emphasis on sterile components and visual quality.

This event will also be the cover Stelmi’s newly in-line production concept, PremiumFill. In a globally controlled area, this concept is aimed at optimizing the microbiological and particulate cleanliness levels in the production of sterile (ready-to-use) and cosmetic quality components (visual aspect).

For an invitation, e-mail contact@stelmi.com or visit Booth 1000.

Almac Adds Potent Containment Capabilities

Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses, Almac (Booth #2600) has successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in its Product Development facility.

The company says that its in-house engineered containment solutions employ rigid and flexible film Isolator technology around the processing zones of equipment that require containment of airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate Almac can process compounds with an OEL as low as 30 ng per m3.

Almac has the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products.

Visit Almac at Booth #2600

Phase Forward Signs Multi-Year EDC Agreement with Quotient Clinical

Phase Forward (Booth 702) has signed a multi-year agreement with Quotient Clinical (Booth 2446) to implement Phase Forward’s InForm Global Trial Management (GTM) electronic data capture (EDC) solution to support data collection, management and analysis for its clinical trials. Quotient Clinical will use Phase Forward’s Central Designer™ module to enhance eCRF design efficiency and improve workflow in the study development process for EDC trials.

“As an innovative provider of early drug development services, we want to ensure that our customers can take advantage of the benefits inherent in using EDC in Phase I trials, including access to high quality data within hours of collection, streamlined process efficiencies and rapid qualification of data,” said David Chalmers, Quotient’s vice president, Biometrics. “We selected InForm because of Phase Forward’s strong position in the marketplace and the company’s experience with Phase I trials.”

By supporting faster accessibility and greater visibility into trial data, the EDC implementation will help Quotient to expand its full-service, in-house Biometrics offering, according to the company. In addition, Quotient plans to offer customers on-line access to trial data, making it easier for them to track progress to date or to review summary reports.

“Quotient’s team is committed to continual expansion of its technical infrastructure to provide advanced services that help customers speed the development process,” said Steve Powell, senior vice president, Phase Forward. “The organization joins the growing number of CROs adopting our InForm product as part of a broader initiative to automate and streamline their Clinical Research Units.”

Vetter Adds U.S. Development Facility

Vetter (Booth 839) will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.

With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.

The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S.,” said Peter Soelkner. “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”

Visit Vetter at Booth 839!

Toxikon Boosts Biologics Safety Program Services

Toxikon Corporation (Booth 1161) has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.

Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”

Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.

A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.

While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.

The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.

Visit Toxikon Corporation at Booth 1161!

Norwich Expands Services with New Pilot Scale Facility

Norwich Pharmaceuticals (Booth 2639) has a newly built and commissioned pilot scale development facility. The new area's features state-of-the-art equipment, according to Norwich, and a company statement said the facility "offers greatly expanded contract outsourcing capabilities enabling them to work with customers earlier on in the development cycle, continuing right through scale up and commercial launch."

With the addition of compatible bench scale equipment, the facility has significantly increased its capabilities. The new equipment includes a four, eight, sixteen quart PK Blend Master with intensifier bar, an Aeromatic MP1 Fluid Bed Dryer, a Vector GMX-10 and GMX-25 Hi-Shear Mixer and a Vector FL-M-1 Flo-Coater. These new additions provide a working range of one to 25 Kgs.

Norwich also recently added new commercial large scale facility capabilities, including a Niro precision coater for the Niro MP5 commercial scale fluid bed to support customer product scale up from the development suite. This three-column coater has a volume range of 30 to 245 liters.

Visit Norwich Pharmaceuticals at Booth 2639!